Senior Quality Assurance Specialist

3 weeks ago


Allentown, United States Germer International - Pharmaceutical Recruiting Full time

Our well estblished pharmaceutical client is looking for a Senior Quality Specialist to join their growing team. Our client is looking for someone to be apart of their crucial success where your contributions and expertise will make a significant impact.


Essential Duties and Responsibilities


  • Responsible for the review, approval, and disposition of finished product for the site and final CoA signature.
  • Client project management as required ensuring “quality on time and in full”.
  • Coordinates the investigation and closure of non-conformances ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed.
  • Leads or participates in focused deviation cross-functional investigations, improvement projects.
  • Reviews and approves laboratory investigations in a timely manner and ensures appropriate root cause is identified
  • Provides assistance to other QA associates and assist with department training.
  • Provides support to QA management during regulatory audits.
  • Reviews BOMs, inspection plans, pallet patterns, calibration records and SOPs.
  • Performs internal audits and assist in writing reports for audits.
  • Maintains and revises procedures related to the quality assurance activities. Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining databases.
  • Maintain the vendor complaint process.
  • Perform Quality inspections on packaging line as needed.
  • Support/Maintain site Document Control System.
  • Review, approve and close out Document change Requests.



Education / Experience

  • Bachelor’s degree in relevant scientific quality assurance / technical field.
  • 5+ years of experience.
  • Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
  • Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels.
  • Expert level user for Quality computer systems.
  • Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems.
  • Thorough understanding of computer system validation and GAMP requirements.



  • Allentown, United States Germer International - Pharmaceutical Recruiting Full time

    Our well estblished pharmaceutical client is looking for a Senior Quality Specialist to join their growing team. Our client is looking for someone to be apart of their crucial success where your contributions and expertise will make a significant impact.Essential Duties and ResponsibilitiesResponsible for the review, approval, and disposition of finished...


  • Allentown, Pennsylvania, United States Maxonic Full time

    Maxonic is dedicated to fostering a strong and enduring partnership with our esteemed client. To meet their requirements, we are seeking a Quality Assurance Specialist III (Medical Device & Manufacturing).Position Overview: Job Title: Quality Assurance Specialist III (Medical Device & Manufacturing)Job Type: Long-term Contract (with potential for extension...


  • Allentown, Pennsylvania, United States Tekwissen Full time

    Job Description**Job Summary:**We are seeking a highly skilled Quality Assurance Specialist to join our team at TekWissen Group. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of clinical products processed through primary and secondary packaging, warehouse, and distribution operations.Key Responsibilities:Apply Good...


  • Allentown, Pennsylvania, United States Integrated Resources, Inc Full time

    Job OverviewPosition Title: Quality Assurance Specialist IIICompany: Integrated Resources, IncJob Summary:This role is integral to the Quality Assurance team, focusing on the evaluation and approval of clinical and commercial documentation. The Quality Assurance Specialist III will ensure compliance with regulatory standards while supporting the Clinical...


  • Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full time

    OverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to enhance the quality assurance processes within a prominent pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained throughout the production cycle.Key ResponsibilitiesOversee the...


  • Allentown, Pennsylvania, United States Keurig Dr Pepper Full time

    Position Overview:The Quality Assurance Specialist plays a vital role in collaborating with Quality, Operations, and Maintenance teams to execute validation and verification tasks during shifts. This position is essential for upholding the Food Safety Management System as required.Shift & Schedule:This is a full-time role on the Night Shift, following a...


  • Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full time

    OverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to enhance our client's established pharmaceutical operations. This role is pivotal in ensuring the quality and compliance of products, contributing significantly to the overall success of the organization.Key ResponsibilitiesOversee the...


  • Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full time

    OverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to contribute to the success of a prominent pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained throughout the production process.Key ResponsibilitiesOversee the evaluation,...


  • Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full time

    OverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to contribute to the success of a well-established pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained throughout the production process.Key ResponsibilitiesOversee the evaluation,...


  • Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full time

    OverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to enhance our client's reputable pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained, contributing significantly to the overall success of the company.Key ResponsibilitiesOversee the...


  • Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full time

    OverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to enhance our client's established pharmaceutical operations. This role is pivotal in ensuring that quality standards are met, contributing significantly to the overall success of the organization.Key ResponsibilitiesOversee the...


  • Allentown, Pennsylvania, United States Joulé Full time

    Job Title: Senior Microbiologist - Quality AssuranceLocation: Allentown, PA Type: Full Time, Salaried with benefits Schedule: M-F A leading organization in the medical device sector is in search of an experienced Microbiologist to enhance their team.Key Responsibilities: Oversee, coordinate, and manage the overall operations of the Microbiological...


  • Allentown, Pennsylvania, United States AlphaGraphics - US207 Full time

    Job OverviewThe Quality Assurance Specialist plays a crucial role in ensuring that all products meet consumer expectations. This position involves a thorough examination of production processes to guarantee adherence to quality standards and the assessment of final products post-production.Key Responsibilities:Establish acceptable variation ranges for...


  • Allentown, Pennsylvania, United States Joulé Full time

    Position: Microbiologist II - GMPLocation: Allentown, PAEmployment Type: Full Time, Salaried with benefitsWork Schedule: Monday to FridayOverview: Joulé is looking for a highly skilled Microbiologist to contribute to our operations in the medical device field. The ideal candidate will possess a strong background in microbiological practices and quality...


  • Allentown, Pennsylvania, United States AlphaGraphics - US207 Full time

    Job OverviewThe Quality Assurance Specialist plays a crucial role in ensuring that products meet consumer expectations. This position involves examining production jobs to verify compliance with quality standards and assessing the final output after manufacturing.Key Responsibilities:Establish acceptable variation ranges for production jobs and identify...


  • Allentown, Pennsylvania, United States TekWissen ® Full time

    Position: Quality Control InspectorLocation: Allentown, PADuration: 12 MonthsJob Type: ContractWork Type: OnsiteShift Timings: Monday-Friday - 03:15 PM to 11:15 PMPay Rate: $26-$26 per hourCompany Overview: TekWissen Group is a prominent workforce management provider, recognized for its expertise in biotechnology product development services. Our client is a...


  • Allentown, Pennsylvania, United States TekWissen LLC Full time

    Job DescriptionOverview: TekWissen Group is a leading provider of workforce management solutions across the USA and internationally. We are currently seeking a Quality Control Inspector for our client, a prominent player in the biotechnology sector, focused on product development services. This organization is committed to delivering essential laboratory...


  • Allentown, Pennsylvania, United States Patterns india Full time

    Job OverviewWe are seeking a meticulous Quality Control Specialist to manage quality assurance activities, encompassing microbiological testing and chemical evaluations, while ensuring compliance with Good Manufacturing Practices (GMP) and upholding the utmost standards of product excellence and safety.Position Details: This is a full-time role based in a...


  • Allentown, Pennsylvania, United States Thermo Fisher Scientific Full time

    Work ScheduleEnvironmental ConditionsJob OverviewAt Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale. Join our dedicated team in fulfilling our Mission daily, empowering our clients to enhance global health, cleanliness, and safety. We equip our international teams with the necessary resources to reach...


  • Allentown, Pennsylvania, United States Thermo Fisher Scientific Full time

    Work ScheduleFirst Shift (Days)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionWhen you are part of the team at Thermo Fisher Scientific, you'll do...